Trial Outcomes & Findings for Effect of Angulus on Patient-elevation Compliance (NCT NCT03496220)
NCT ID: NCT03496220
Last Updated: 2024-03-06
Results Overview
Measured as a continuous variable between 0% and 100% compliance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
3 months
Results posted on
2024-03-06
Participant Flow
Participant milestones
| Measure |
ICU A Feedback First, Then no Feedback, and Feedback Last
During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.
In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Angulus: Feedback on patient recumbency
|
ICU B No Feedback First, Then Feedback, and No Feedback Last
During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.
In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Angulus: Feedback on patient recumbency
|
ICU C: Feedback First, Then No Feedback, and Feedback Last
During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.
In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Angulus: Feedback on patient recumbency
|
|---|---|---|---|
|
First Intervention
STARTED
|
15
|
4
|
10
|
|
First Intervention
COMPLETED
|
15
|
4
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
17
|
9
|
11
|
|
Second Intervention
COMPLETED
|
17
|
9
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
11
|
8
|
5
|
|
Third Intervention
COMPLETED
|
11
|
8
|
5
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Angulus on Patient-elevation Compliance
Baseline characteristics by cohort
| Measure |
Feedback
n=49 Participants
The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.
Angulus: Feedback on patient recumbency
|
No Feedback
n=41 Participants
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Angulus: Feedback on patient recumbency
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
58.7 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
41 participants
n=107 Participants
|
90 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Time spent in evidence based recumbency range comparison.
Measured as a continuous variable between 0% and 100% compliance.
Outcome measures
| Measure |
Feedback
n=49 Participants
The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.
Angulus: Feedback on patient recumbency
|
No Feedback
n=41 Participants
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Angulus: Feedback on patient recumbency
|
|---|---|---|
|
Compliance to Head of Bed Elevation to 30 Degree or More.
|
37.3 percentage of time
Standard Deviation 26.2
|
32.4 percentage of time
Standard Deviation 29.3
|
Adverse Events
Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place